After 30 years of treating approximately 9,000 patients and tired of the ‘therapeutic stagnation’ in this disease, he called on the FDA to ‘execute a therapeutic strategy’ that would pave the way for drug development. No doubt speaking not just to the FDA but to drug company reps listening, he gave them good pragmatic reasons to do so; 1,000,000 sick people in the US, a $9 billion hit to our economy yearly, a market for a diagnostic marker yielding potentially $250 million a year, a drug therapy possibly bringing in billions….
“I implore the esteemed committee to develop a therapeutic strategy for ME/CFS” Dr. Dan Peterson to FDA
Listen to Dr. Peterson at minute 92:00 of this VIDEO.
He didn’t ask the federal government to do it all on their own. The ME/CFS physician community he asserted is ready to do its part. They’re already using objective markers such as NK cell functioning, MRI’s, SPECT scans, low VO2 max tests to inform their therapies and they have formed the consortia and networks needed to take on pilot studies and multi-center Phase I, II and III clinical trials.
He was backed up by his longtime colleague, Dr. Nancy Klimas later in the meeting when she said ” much of what is needed to develop drugs for ME/CFS is ‘already in hand’; we have, she said, the ‘clinical trials groups’ who have ‘many, many years of experience with these…instruments we’ve been talking about’. “There’s really no reason to delay any further”
“There’s really no reason to delay any further” Dr. Nancy Klimas on targeted clinical trials for ME/CFS at the FDA Stakeholder’s meeting
The key problem is the large heterogeneous population that makes up the ME/CFS community. Dr. Slagle of the FDA noted that the heterogeneity of the ME/CFS patient population made it necessary for researchers to define and target specific subsets, but both Dr. Klimas and Dr. Peterson asserted they’re ready, right now, to bring targeted therapies to bear on just those subsets.
This is all about one thing; scientifically redefining ME/CFS … wherever that takes us … and as long as it leads to treatments.
Scientifically Redefining ME/CFS
Dr. Peterson’s report of Vistide’s success in a retrospective study of severely ill ME/CFS with herpesvirus infections constituted not just an attempt to provide better treatment options but to redefine this illness using biological variables; in this case a subset of patients with active cytomegalovirus infections who responded to Vistide.
The Chronic Fatigue Initiative’s Hornig/Lipkin pathogen study will, with the addition of Simmaron’s spinal fluid samples, contribute to this process if they illuminate a distinct subset of patients with active viral infections, as suggested by Madie Hornig in Florida. (Results are due within the next two months.)
Now comes convincing the pharmaceutical industry that it’s worth their while to invest in this disorder, and that’s where Dr. Peterson’s request for a ‘therapeutic strategy’ that will compel pharma to enter the market comes in. That therapeutic strategy will involve the FDA identifying endpoints for subpopulations and study designs that industry will have confidence in.
Is the FDA ready to do that?